BridgeMD
Compares treatment options for Fecal Incontinence
Official title Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence
ClinicalTrials.gov ID: NCT07604415
What this study is testing
- What it's testing
- Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent
- Age ≥18 years
- Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or...
- Vaizey (St. Mark's) Incontinence Score ≥8
- Ability to understand study procedures and comply with the 12-week home intervention
You likely can't join if
- Complete spinal cord injury above the conus medullaris
- Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission
- Rectal prolapse requiring surgical intervention
- Severe symptomatic hemorrhoids interfering with anorectal assessments or device use
- Active anal fissure or perianal fistula
- Active colorectal cancer or history of colorectal cancer within 5 years
See the full eligibility criteria
- Signed informed consent
- Age ≥18 years
- Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months
- Vaizey (St. Mark's) Incontinence Score ≥8
- Ability to understand study procedures and comply with the 12-week home intervention
- Willingness to attend all study visits and assessments
- Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment
- Complete spinal cord injury above the conus medullaris
- Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission
- Rectal prolapse requiring surgical intervention
- Severe symptomatic hemorrhoids interfering with anorectal assessments or device use
- Active anal fissure or perianal fistula
- Active colorectal cancer or history of colorectal cancer within 5 years
- Colorectal surgery within the previous 6 months
- Pregnancy or planned pregnancy during study participation
- Implanted cardiac pacemaker or defibrillator
- Other implanted electrical devices contraindicating electrical stimulation
- Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization
- Cognitive impairment preventing understanding of study procedures or informed consent
- Uncontrolled severe diarrhea (\>5 liquid stools/day)
- Anal stenosis preventing probe insertion
- Severe anal sphincter defect (\>120° on ultrasound) requiring surgical repair
- Isolated severe rectal sensory dysfunction without significant sphincter dysfunction
- Previous pelvic radiotherapy
- Concurrent participation in another treatment clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Martin, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Martin, Slovakia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.